๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-12

A Phase 3 Single-arm Study of UGN-104 for the Treatment of Low-grade Upper Tract Urothelial Cancer (NCT06774131)

A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC)

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: UroGen Pharma Ltd.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This study will evaluate the efficacy and safety of UGN-104, a new formulation of UGN-101 (approved in the United States and Israel as JELMYTO \[mitomycin\] for pyelocalyceal solution), instilled in the upper urinary tract (UUT) of patients with low-grade upper tract urothelial cancer (LG-UTUC).

Who can join: Review the eligibility criteria below.

Location: Urology Centers of Alabama โ€” Homewood, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (62 Sites)

Showing the first 25 of 62 sites.

  • Urology Centers of Alabama โ€” Homewood, Alabama
  • Arizona State Urological Research Institute, LLC ("ASURI") โ€” Chandler, Arizona
  • East Valley Urology Center of Arizona โ€” Queen Creek, Arizona
  • University of Arkansas for Medical Sciences โ€” Arkansas City, Arkansas
  • Michael G Oefelein Clinical Trials โ€” Bakersfield, California
  • UC Irvine Health. Chao Family Comprehensive Cancer Center โ€” Orange, California
  • Bioresearch Partner - Aventura โ€” Aventura, Florida
  • University of Florida Health (UF Health), Cancer Center โ€” Gainesville, Florida
  • Bioresearch Partner - Hialeah Hospital โ€” Hialeah, Florida
  • D&H National Research Centers - Cancer Research Center, LLC โ€” Margate, Florida
  • Urology Center of Iowa Research โ€” Clive, Iowa
  • The Urology Center, P.C. โ€” Omaha, Nebraska
  • Montefiore Medical Center - Bronx โ€” The Bronx, New York
  • University of Cincinnati Medical Center (UCMC) โ€” Cincinnati, Ohio
  • The James Cancer Hospital and Solove Research Institute โ€” Columbus, Ohio
  • Urologic Specialists of Oklahoma โ€” Tulsa, Oklahoma
  • Penn State Milton S Hershey Medical Center โ€” Hershey, Pennsylvania
  • Medical University of South Carolina โ€” Charleston, South Carolina
  • Carolina Urologic Research Center, LLC โ€” Myrtle Beach, South Carolina
  • Low county Urology Clinics โ€” North Charleston, South Carolina
  • Amarillo Urology Research โ€” Amarillo, Texas
  • UPNT Research Institute, LLC โ€” Arlington, Texas
  • Texas Urology Specialists-Austin โ€” Austin, Texas
  • Renovatio Clinical - The Woodlands Research Center โ€” The Woodlands, Texas
  • University of Virginia Comprehensive Cancer Center โ€” Charlottesville, Virginia

๐Ÿ“ž Contact the Study Coordinator

Phone: (346) 573-2671

Email: renee.sumlin@urogen.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—